Secondary Insert

GUDID 00852598007417

Secondary Cylinder Insert

AUGUSTA MEDICAL SYSTEMS, L.L.C.

Penile vacuum device
Primary Device ID00852598007417
NIH Device Record Keyccc4e0e3-319f-4a93-9105-3a3a49e72b5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecondary Insert
Version Model NumberCylinder Insert
Company DUNS052255606
Company NameAUGUSTA MEDICAL SYSTEMS, L.L.C.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-827-8382
Emailsomatherapy@augustams.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852598007417 [Primary]

FDA Product Code

LKYDevice, External Penile Rigidity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-17

Devices Manufactured by AUGUSTA MEDICAL SYSTEMS, L.L.C.

00852598007004 - Response II2018-03-29 Manual vacuum pump
00852598007011 - Soma Therapy OTC2018-03-29 Manual Vacuum Pump
00852598007028 - Elite Custom2018-03-29 Manual Vacuum Pump
00852598007035 - Somaerect Stf2018-03-29 Manual Vacuum Pump
00852598007042 - Touch II2018-03-29 Battery Vacuum Pump
00852598007059 - Soma Therapy OTC Plus2018-03-29 Battery Vacuum Pump
00852598007066 - Somaerect Stf Plus2018-03-29 Battery Vacuum Pump
00852598007073 - Elite Custom Plus2018-03-29 Battery Vacuum Pump

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